Last updated 2 months ago
A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
332 patients around the world
Available in Puerto Rico, Argentina, United States
ViiV Healthcare
6Research sites
332Patients around the world
This study is for people with
Hiv
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- Aged >=12 years and >=35 kg at the time of obtaining informed consent.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL.Plasma HIV-1 RNA >1 000 c/mL and greater than <100 000 c/mL at Screening.Evidence of insufficient virologic response to participant's current oral ART regimen within 18 months prior to study entry according to at least 1 of the following criteria.Less than 1 log10 decrease in HIV-1 RNA or HIV-1 RNA >200 c/mL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months.Documented lapse in current oral ART regimen usage expected to result in HIV-1 viremia defined as at least a 30-day consecutive period of non-use of oral ART.Documented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response.Currently being treated with an oral ART regimen specific regimen to be recorded at Screening, and willing to continue taking that regimen until approximately 1 week after the Month 6 visit.Person of childbearing potential must have a negative serum or urine pregnancy test at screening and on Day 1.Adult participants must be capable of giving signed informed consent as described in the full study protocol.For adolescent participants, the parent(s) or legal guardian must be capable of giving signed informed consent.
- HIV-1 Subtype A6, if known from historical result.Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study.Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice.Individuals with both HIV and Hepatitis B virus will be excluded from participating in studies where they would not be able to receive appropriate therapy for their HBV co-infection.History of liver cirrhosis with or without hepatitis viral co-infection.Participants with severe hepatic impairment as determined by Child-Pugh classification.Participants with HCV co-infection will be excluded entry into this study if they are currently receiving anti-HCV therapy at baseline.Participants determined by the investigator to have a high risk of seizures.History of sensitivity to any of the study medications or their components or drugs of their class.Participants who in the investigator's judgment pose a significant suicidality risk.Any pre-existing physical or mental condition which may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations.Any previous use of CAB.Current or anticipated need for chronic anti-coagulants.Use of concomitant medications which are associated with Torsades de Pointes.Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.Treatment with radiation therapy within 28 days of Screening.Treatment with cytotoxic chemotherapeutic agents within 28 days of Screening.Treatment with tuberculosis therapy with the exception of isoniazid within 28 days of Screening.Treatment with anti-coagulation agents, with the exception of the use of low dose acetylsalicylic acid.Treatment with immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons within 28 days of Screening.Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational medicinal product.Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.Participant is currently participating in, or anticipates being selected for, any other interventional study.Any evidence of viral drug resistance based on the presence of any major RAM to INSTIs or NNRTIs in the Screening result.Any acute laboratory abnormality at Screening, which would preclude the participant's participation in the study of an investigational compound.Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities.ALT >=5 times ULN or ALT >=3×ULN and bilirubin >=1.5×ULN.eGFR of <30 mL/min/1.73 m2 via refitted, race-neutral CKD-EPIcr_R method or <50 mL/min/1.73 m2 using the Bedside Schwartz equation.Hemoglobin <9.0 g/dL.Corrected QT interval QTc >450 msec or QTc >480 msec for participants with bundle branch block.Unwilling to receive injections, or unable to receive gluteal injections.The participant has gluteal implants or prosthesis or a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reaction.Evidence of alcohol or substance use disorder within the previous 12 months that would interfere with the participant's safety.Adolescents who are wards of the state or government.
Sites
STAT Research - CABA
Recruiting
Fundación Huésped - Buenos Aires
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Instituto CAICI - Rosario, Santa Fe
Recruiting
Instituto Oulton - Córdoba
Recruiting
Fundacion IDEAA
Recruiting
StudyCROWN
SponsorViiV Healthcare
Study typeInterventional
Conditions
Hiv
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06694805
